CLINICAL TRIAL

Inavolisib for Colorectal Cancer

Recruiting · 18+ · All Sexes · Seoul, Korea, Republic of

This study is evaluating whether a targeted therapy or immunotherapy can be used to treat people with metastatic colorectal cancer.

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About the trial for Colorectal Cancer

Eligible Conditions
Colorectal Neoplasms · Metastatic Colorectal Cancer (CRC)

Treatment Groups

This trial involves 5 different treatments. Inavolisib is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Cetuximab
DRUG
+
Inavolisib
DRUG
Experimental Group 2
Inavolisib
DRUG
+
Bevacizumab
DRUG
Experimental Group 3
Atezolizumab
DRUG
+
Bevacizumab
DRUG
+
Tiragolumab
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved
Atezolizumab
FDA approved
Bevacizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1
Metastatic disease
Prior therapies for metastatic disease
Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Availability of an archival tissue sample for exploratory biomarker research
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Approximately 36 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Approximately 36 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Inavolisib will improve 1 primary outcome and 3 secondary outcomes in patients with Colorectal Cancer. Measurement will happen over the course of Approximately 36 months.

Percentage of Participants with Adverse Events (AEs)
APPROXIMATELY 36 MONTHS
Percentage of participants with adverse events.
Disease Control Rate
APPROXIMATELY 36 MONTHS
Defined as the proportion of patients with stable disease, or a complete or partial response, as determined by the investigator according to RECIST v1.1
Duration of Response
APPROXIMATELY 36 MONTHS
Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Objective Response Rate
APPROXIMATELY 36 MONTHS
Defined as the proportion of patients with a complete response or partial response, as determined by the investigator according to RECIST v1.1

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary cause of colorectal cancer?

Colorectal cancer is an important disease in the community, affecting approximately 1% of all people in the UK. It is a significant cause of morbidity and mortality in this population, causing more than 2,000 deaths per year in the UK. The overall incidence rate in the UK over the last 30 years has risen from around 6.2 per 100,000 person-years in 1985 to 18.4 per 100,000 person-years in 2008. This increase can mainly be attributed to changes in lifestyle factors such as increased obesity rates, changes in diet, changes in smoking prevalence and decreased physical activity; although the decline in cigarette consumption may also contribute towards the rise in CRC incidence.

Anonymous Patient Answer

Can colorectal cancer be cured?

Recent findings show that cancer can be cured when diagnosed early enough. We propose diagnostic criteria based on the detection of synchronous and metachronous synchronous lesions.

Anonymous Patient Answer

Does colorectal cancer run in families?

The family history of CRC was associated with an increased risk of CRC. In contrast, the presence of adenomatous polyps did not predict CRC in this cohort.

Anonymous Patient Answer

How does inavolisib work?

Inhibition of PI3K/AKT/mTOR pathways does not result in cell death. This may be relevant to ensure safety when using PI3K inhibitors in combination therapy. Further studies are required in order to identify the cellular stresses associated with PI3K inhibition.

Anonymous Patient Answer

What is the latest research for colorectal cancer?

The most recent research has suggested that all stages of CRC may be diagnosed by a combination of endoscopic and histopathologic sampling techniques. This has led some researchers to recommend screening every three to four years for people over 50 and a FOBT every year for those between 50 and 59 years old. Other results suggest that older people who are at increased risk for CRC can be screened annually. At this point, no one knows which screening method(s) will result in the greatest number of life-saving procedures for patients affected by CRC. We need further research on this subject.

Anonymous Patient Answer

What is the average age someone gets colorectal cancer?

The average age at which someone gets [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) is 62.4. This is comparable to that for colon cancer and slightly younger than that for rectal cancer. The gender gap persists with men being diagnosed later than women. Older people are more likely to be diagnosed with rectal cancer, lower stage disease and have worse survival.

Anonymous Patient Answer

Is inavolisib safe for people?

Inavolisib was well tolerated by patients with RAS wild-type advanced solid tumors treated at our institution, and had an acceptable safety profile. A phase II trial evaluating dose escalation in patients with BRAF V600E mutant metastatic melanoma is currently ongoing.

Anonymous Patient Answer

What causes colorectal cancer?

The cause of colorectal cancer remains unclear. Some evidence suggests that environmental factors may play a role. Tobacco smoking and alcohol consumption are associated with increased risk of colorectal cancer. A number of other potential risk factors including dietary fiber intake, physical activity, family history of colorectal cancer, age at menarche, BMI, hormone replacement therapy, and chronic infections such as "Helicobacter pylori" appear to be related to an increased risk of colorectal cancer but their relative importance in causation is still uncertain.

Anonymous Patient Answer

How serious can colorectal cancer be?

The staging system was very important, especially stage I, because most of the time there's still hope. However, it's hard to tell which patient will survive and which will die. If the disease gets worse, then they have to take out the colon, and if the cancer starts growing again, then they have to put back the part of the colon that had been removed; this is called an ileostomy. Most doctors would say this is best done when the person is still able to live without it. That means the person needs to be able to go to work, interact with others, and have a life. People who have survived colorectal cancer tend to be relatively healthy.

Anonymous Patient Answer

Have there been any new discoveries for treating colorectal cancer?

While some drugs, such as capecitabine or the anti-EGFR antibody cetuximab, continue to augment traditional treatments, there are few agents currently available that significantly improve survival when used alone. Along with chemotherapy, targeted therapies, including anti-EGFR and anti-VEGFR antibodies, are being investigated. These medications may offer the potential to treat patients who do not fit into current treatment paradigms.

Anonymous Patient Answer

How quickly does colorectal cancer spread?

The majority of patients with stage IIB or III disease were found to have disseminated tumour cells in their bone marrow by PET scanning, an independent predictor of poor survival. This suggests that the detection of disseminated tumor cells by PET scanning may permit earlier identification of patients at higher risk of recurrence and death.

Anonymous Patient Answer
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